跳至主要内容
临床试验/NCT04425720
NCT04425720已完成不适用

Use of Remote Patient Monitoring (RPM) Platform for COVID-19 Patient

Montefiore Medical Center2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
300
试验地点
2
主要终点
Number of Monitored Versus Non-Monitored In-patient Admission

研究概览

简要总结

The central hypothesis motivating this study is that remote patient monitoring (RPM) of infectious disease patients can efficiently facilitate self-isolation. Additionally, RPM can assist in more rapid identification of patients at risk, facilitate detection of patient deterioration, and enable early interventions, all of which play a vital role in resource utilization and outcomes.

详细描述

Aim-I To develop and test a clinical care pathway that can be utilized in similar epidemic conditions in the future. To study this aim, the investigators will be using the COVID-19 medical surge as a condition to evaluate the framework of delivering care through remote patient monitoring. The success of this care delivery model will be evaluated on ease of model implementation, patient satisfaction, clinical outcomes, and the utilization of shared decision making.

Aim-II To evaluate remote patient monitoring for appropriate resource utilization in epidemic and pandemic conditions. To evaluate this aim, the investigators plan to compare the emergency department (ED) visits and in-patient admission of patients with and without wearable remote patient monitoring devices. Additionally, the investigators will compare the number of patients that required critical interventions (mechanical ventilation and ECMO) during the hospital stay.

Aim III To evaluate the utilization of wearable technology for upfront predictions of patients that would require in-patient admissions. To evaluate this aim, patients who are diagnosed with COVID-19 and are undergoing self-quarantine will be closely monitored using a wearable device, and shared-clinical decisions will be made based on the monitored data and patient diary. The comparison group will be patients undergoing routine standard of care at the hospital. ED visits, in-patient hospital admissions, and patient satisfaction will be the outcome measures compared between the two groups.

Aim IV To evaluate the association between early identification of critical, abnormal vital signs and the prevention of serious adverse events. To evaluate this aim, patients in the monitored group and non-monitored group will be compared for ED visits, in-patient admissions, length of hospital stay, and serious adverse events.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Covid-19 positive patient
  • Does not require in-patient admission

排除标准

  • Allergic to sensor patch
  • Has implanted pacemaker
  • Has excessive sweating

结局指标

主要结局

Number of Monitored Versus Non-Monitored In-patient Admission

时间窗: 14 days

compare the number of in-patient admissions between the monitored and non-monitored patients

How Many Subjects Needed to Visit the Emergency Department

时间窗: 14 days

compare the number of participants who visited Emergency Department between both arms

Length of Stay

时间窗: 14 days

Length of stay of subject if hospitalized

How Many Completed the Patient Satisfaction Survey

时间窗: 14 days

Survey given to patients who were monitored to ask about satisfaction with the program. A research associate calls enrolled subjects to determine their opinions having participated in the program.

How Many Subjects End up Requiring Mechanical Ventilation and ECMO

时间窗: 14 days

How often does a subject end up getting mechanical ventilation or ECMO

Serious Adverse Events

时间窗: 14 days

events requiring extended hospital stay

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验